Smoking
Conditions
Brief summary
This decentralized clinical trial assesses the feasibility of conducting a tobacco product evaluation study remotely via telehealth visits and mailed samples. This is an open label, between-subject, randomized pilot study to assess the effect of minimal filter ventilation vs. moderate filter ventilation on smoking behavior and biomarkers of exposure (e.g. nicotine, carbon monoxide) in menthol smokers switched to non-menthol cigarettes. Subjective measures, alveolar carbon monoxide, blood pressure and cigarettes smoked per day will be collected remotely. Biological samples will be collected at home and mailed into the clinic.
Interventions
OTHERMinimally Ventilated non-menthol cigarettes
4 week intervention where participants will be using minimally ventilated non-menthol cigarettes. Weekly telehealth visits will be conducted during baseline and the 4 weeks on study cigarettes to collect study measures followed by a follow-up one month after end of intervention.
OTHERVentilated non-menthol cigarettes
4 week intervention where participants will be using ventilated non-menthol cigarettes. Weekly telehealth visits will be conducted during baseline and the 4 weeks on study cigarettes to collect study measures followed by a follow-up one month after end of intervention.
Sponsors
Masonic Cancer Center, University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Open label, between-subject, randomized multi-center pilot study
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or females at least 21 years of age or older * Smoking menthol cigarettes most of the time (80% of cigarette purchases). * Self-report of daily smoking of at least 5 - 25 cigarettes for \>3 months by self-report. * Carbon monoxide indicative of regular smoking (CO \> 6ppm) prior to randomization. * Has regular access to a smartphone or tablet for use with CO device and smartphone, tablet or computer with functioning camera and internet access for telehealth visits and surveys.
Exclusion criteria
* Unstable health conditions (any significant serious, unstable medical condition including, but not limited to, cardiovascular disease, liver or kidney disease, COPD, bronchitis, within the past 3 months, seizure disorder and cancer (cancer-free \<5 years except some skin cancers can be within 5 years), or a COVID-19 positive test or COVID-19 symptoms in the last 30 days or as determined by the licensed medical professional at each site). * Unstable mental health (to be determined by medical history, Patient Health Questionnaire-2 (Prime-MD) and GAD-2 after review by the licensed medical professional at each site). * Excessive drinking or problems with drinking or drugs (assessed by PI or licensed medical professional). * Currently pregnant, breastfeeding or intending to become pregnant for the duration of the study or unwilling to agree to use adequate protection to avoid pregnancy. * Taking exclusionary medications, unstable dosing of medications, or unstable control of symptoms for ongoing medical conditions (medications or conditions that would impact biomarkers or patient safety to be determined by the licensed medical professional). * Vital signs outside of the following range: * Systolic BP greater than or equal to 160 * Diastolic BP greater than or equal to 100 * Systolic BP below 90 and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint) * Diastolic BP below 50 and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint) * Heart rate greater than or equal to 105 bpm * Heart rate lower than 45 bpm and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint) (Participants failing for heart rate or blood pressure will be allowed to re-screen once). * Household member enrolled in the study concurrently. * Participated in prior research study during the past three months that would impact baseline smoking or response to study products. * Inability to independently read and comprehend the consent form and follow other written study instructions, materials or measures or behavior indicating inability to fully participate in study procedures. Participants are required to complete the protocol at home independently and must show ability to comply with directions. * Unstable living environment that would compromise the ability to sequester study products or complete study procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Approach - Data Collection | Baseline through Week 4 | Percent reporting difficulty collecting data in the Study Feasibility Questionnaire and interview |
| Percentage of Participants That Dropped Out | Baseline through Week 4 | Percentage of Participants that dropped out by week 4. |
| Cigarettes Smoked Per Day | Baseline through Week 4 | Change in mean Cigarettes Per Day (CPD) based on 7 day ITR data before visit. Randomized participants (low vs moderate FV), between-group difference in change in cigarettes per day from baseline to Week 4, comparing low-ventilated versus moderate-ventilated non-menthol cigarette groups. Cigarettes per day (CPD) was calculated as the mean number of cigarettes smoked per day based on daily self-reported cigarette use collected via interactive text response (ITR) surveys. Change scores were computed as the difference between the mean CPD at Week 4 and the mean CPD at baseline for each participant, and group differences reflect the between-arm difference in these change scores. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cotinine Change | Baseline through week 4 | Change in cotinine from baseline to the week 4 visit. Randomized participants (low vs moderate FV), between-group difference in cotinine from baseline to Week 4, comparing low-ventilated versus moderate-ventilated non-menthol cigarette groups. Cotinine was measured from blood samples collected using volumetric absorptive micro sampling (VAMS) and analyzed using liquid chromatography-mass spectrometry. Due to skewness, cotinine values were log-transformed, and change was calculated as the log ratio of Week 4 to baseline levels. Group differences represent the between-arm difference in these log-transformed changes. |
| Carbon Monoxide Changes | Baseline through Week 4 | Change in Carbon Monoxide from baseline to the week 4 visit. Randomized participants (low vs moderate FV), between-group difference in carbon monoxide from baseline to Week 4, comparing low-ventilated versus moderate-ventilated non-menthol cigarette groups. Exhaled carbon monoxide (ppm) was measured remotely using a portable CO monitor during scheduled study visits. Change scores were calculated as Week 4 minus baseline CO levels for each participant, and group differences represent the between-arm difference in these change scores. |
| Quit Attempts | Baseline through Week 4 | Number of 24 hour quit attempts analyzed using regression estimate. Randomized participants (low vs moderate FV), between-group difference in quit attempt from baseline to Week 4, comparing low-ventilated versus moderate-ventilated non-menthol cigarette groups. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDorothy Hatsukami, PH.D
Masonic Cancer Center, University of Minnesota
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 44 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 27 Participants |
| Region of Enrollment United States | 46 participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 23 |
| other Total, other adverse events | 5 / 23 | 10 / 23 |
| serious Total, serious adverse events | 0 / 23 | 2 / 23 |
Outcome results
None listed